” We are proud to announce that we can now offer KYBELLA™, a newly FDA approved medicine for unwanted fat under the chin (“double chin”) for our patients. Dr. Hruza is a certified Kybella trainer and teaches other physicians around the country how to safely inject Kybella. Laser & Dermatologic Surgery Center is one of the first two practices in the St. Louis region to offer this non-surgical treatment to their patients. “
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) announced today (April 29, 2015) that the U.S. Food and Drug Administration (FDA) has approved KYBELLA™, also known as ATX-101, “for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
” KYBELLA™ is the first and only approved non-surgical treatment for reduction of submental fullness, a common yet under-treated aesthetic condition. Photos accompanying this release are available at http://www.globenewswire.com/
“For the first time, people have access to an FDA-approved, non-surgical treatment for submental fullness, a condition that can negatively impact the overall appearance of the face and can result in a person feeling older and heavier,” said Keith Leonard, President and Chief Executive Officer of KYTHERA. “With KYBELLA™, physicians can offer a clinically-proven treatment that is customized to the patient and their treatment goals for an improved chin profile. Importantly, KYBELLA™ treatment resulted in high patient satisfaction.”
KYBELLA™ is supported by a global clinical development program that includes over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with KYBELLA™.i In the pivotal Phase III studies, 68.2 percent of patients responded to KYBELLA™ based on a composite of validated physician and patient measurements.ii Patients treated with KYBELLA™ reported an improvement in the amount of fat in the area under the chin. Patients also reported improvement in the emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.
The most common adverse reactions were associated with the injection site and included swelling, bruising, pain, numbness, erythema and formation of small areas of firmness around the treatment area. The percentage of adverse reactions reported as mild were 81 percent, moderate 17.4 percent, and severe 1.6 percent.
KYBELLA™ is administered by injections into the fat under the chin, tailored to the treatment goals of the patient and the physician. Each in-office treatment session is typically 15-20 minutes. Many patients experienced visible results in two to four treatments.iii Up to six treatments may be administered. Once the aesthetic response is achieved, retreatment is not expected.
“A recent consumer survey by the American Society for Dermatologic Surgery revealed that 68 percent of consumers are bothered by fullness under their chin,” said George J. Hruza, M.D., President of the American Society for Dermatologic Surgery. “KYBELLA™ provides physicians with the first non-surgical treatment option to satisfy this unmet patient need.”